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Short-course Preoperative Chemoradiotherapy for Rectal Cancer (KROG 11-02)

This study is currently recruiting participants.
Verified September 2011 by Seoul St. Mary's Hospital
Sponsor:
Collaborators:
Seoul National University Hospital
Samsung Medical Center
National Cancer Center, Korea
Information provided by (Responsible Party):
Jong Hoon Lee, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT01431599
First received: September 6, 2011
Last updated: September 9, 2011
Last verified: September 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the early clinical outcome of the short-course preoperative chemoradiotherapy, 33Gy/10 fx and delayed operation after chemoradiation, the investigators initiated the clinical trial of KROG 11-02.


Condition Intervention Phase
Rectal Cancer
 Radiation: short-course radiation
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Two Week-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Rectal Cancer: Phase II Multicenter Clinical Trial (KROG 11-02)

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Seoul St. Mary's Hospital:

Primary Outcome Measures:
  • downstaging effect of tumor [ Time Frame: an expected average of 6 weeks after chemoradiation ] [ Designated as safety issue: No ]
    Comparison of clinical T staging and pathologic T staging example> cT4 --> pT1 after chemoradiation: down staging (+)


Secondary Outcome Measures:
  • bladder and small bowel toxicity after chemoradiation [ Time Frame: Participants will be followed for an expected average of 3 months after chemoradiation ] [ Designated as safety issue: Yes ]
    The incidence of grade 3 or higher small bowel and bladder toxicity according to the RTOG and EORTC toxicity criteria (reference: Cox JD et al. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6)


Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: short-course Radiation: short-course radiation
33Gy/10 fractions

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. histologically confirmed adenocarcinoma
  2. distal margin of the tumor located < 8 cm above the anal verge
  3. cT3-4 or cN+ classification as determined by endorectal ultrasonography (EUS) and CT
  4. patient older than age 18 years
  5. Karnofsky performance score >= 70

Exclusion Criteria:

  1. distant metastasis identified during staging workup
  2. previous or concurrent malignancy
  3. pregnant or breast-feeding women
  4. impending rectal obstruction
  5. familial adenomatous polyposis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431599

Contacts
Contact: Jong Hoon Lee, MD 82-010-8607-1269 koppul@catholic.ac.kr

Locations
Korea, Republic of
National Cancer Center, Korea Recruiting
Goyang, Korea, Republic of
Contact: Dae Yong Kim, MD         radiopiakim@hanmail.net    
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Eui Kyu Chie, MD         ekchie93@SNU.ac.kr    
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Hee Chul Park, MD         hee.ro.park@samsung.com    
Sponsors and Collaborators
Seoul St. Mary's Hospital
Seoul National University Hospital
Samsung Medical Center
National Cancer Center, Korea
Investigators
Principal Investigator: Hong Seok Jang, MD Department fo Radiation Oncology, Seoul St. Mary's Hospital
  More Information

Publications:

Responsible Party: Jong Hoon Lee, Dr., Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01431599     History of Changes
Other Study ID Numbers: KROG 11-02
Study First Received: September 6, 2011
Last Updated: September 9, 2011
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Seoul St. Mary's Hospital:
Locally advanced rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013